Latest & greatest articles for sofosbuvir

The Trip Database is a leading resource to help health professionals find trustworthy answers to their clinical questions. Users can access the latest research evidence and guidance to answer their clinical questions. We have a large collection of systematic reviews, clinical guidelines, regulatory guidance, clinical trials and many other forms of evidence. If you wanted the latest trusted evidence on sofosbuvir or other clinical topics then use Trip today.

This page lists the very latest high quality evidence on sofosbuvir and also the most popular articles. Popularity measured by the number of times the articles have been clicked on by fellow users in the last twelve months.

What is Trip?

Trip is a clinical search engine designed to allow users to quickly and easily find and use high-quality research evidence to support their practice and/or care.

Trip has been online since 1997 and in that time has developed into the internet’s premier source of evidence-based content. Our motto is ‘Find evidence fast’ and this is something we aim to deliver for every single search.

As well as research evidence we also allow clinicians to search across other content types including images, videos, patient information leaflets, educational courses and news.

For further information on Trip click on any of the questions/sections on the left-hand side of this page. But if you still have questions please contact us via jon.brassey@tripdatabase.com

Top results for sofosbuvir

1. Sofosbuvir?velpatasvir?voxilaprevir for treating chronic hepatitis C

Sofosbuvir?velpatasvir?voxilaprevir for treating chronic hepatitis C Sofosbuvir–v Sofosbuvir–velpatasvir–v elpatasvir–vo oxilapre xilaprevir for vir for treating chronic hepatitis C treating chronic hepatitis C T echnology appraisal guidance Published: 21 February 2018 nice.org.uk/guidance/ta507 © NICE 2018. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and-conditions#notice-of- rights).Y Y our responsibility our responsibility The recommendations (...) and to reduce health inequalities. Commissioners and providers have a responsibility to promote an environmentally sustainable health and care system and should assess and reduce the environmental impact of implementing NICE recommendations wherever possible. Sofosbuvir–velpatasvir–voxilaprevir for treating chronic hepatitis C (TA507) © NICE 2018. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and- conditions#notice-of-rights). Page 2 of 17Contents Contents 1 Recommendations

2018 National Institute for Health and Clinical Excellence - Technology Appraisals

2. Ledipasvir-sofosbuvir for treating chronic hepatitis C

Ledipasvir-sofosbuvir for treating chronic hepatitis C L Ledipasvir–sofosbuvir for treating edipasvir–sofosbuvir for treating chronic hepatitis C chronic hepatitis C T echnology appraisal guidance Published: 25 November 2015 nice.org.uk/guidance/ta363 © NICE 2018. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and-conditions#notice-of- rights).Y Y our responsibility our responsibility The recommendations in this guidance represent the view of NICE, arrived (...) . Commissioners and providers have a responsibility to promote an environmentally sustainable health and care system and should assess and reduce the environmental impact of implementing NICE recommendations wherever possible. Ledipasvir–sofosbuvir for treating chronic hepatitis C (TA363) © NICE 2018. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and- conditions#notice-of-rights). Page 2 of 85Contents Contents 1 Guidance 5 T able 1 Ledipasvir–sofosbuvir for treating adults

2015 National Institute for Health and Clinical Excellence - Technology Appraisals

3. Real-world effectiveness and safety of sofosbuvir/velpatasvir and ledipasvir/sofosbuvir hepatitis C treatment in a single centre in Germany. Full Text available with Trip Pro

Real-world effectiveness and safety of sofosbuvir/velpatasvir and ledipasvir/sofosbuvir hepatitis C treatment in a single centre in Germany. Newer direct-acting antiviral therapies are increasingly becoming the therapy of choice in patients with hepatitis C virus (HCV) infection. Here, we report the safety and effectiveness of sofosbuvir/velpatasvir (SOF/VEL) and ledipasvir/sofosbuvir (LDV/SOF) in real-world cohorts in Germany.Patients initiated on SOF/VEL 12 weeks or LDV/SOF 8, 12 or 24 weeks

2019 PLoS ONE

4. Sofosbuvir?velpatasvir for treating chronic hepatitis C

Sofosbuvir?velpatasvir for treating chronic hepatitis C Sofosbuvir–v Sofosbuvir–velpatasvir for treating elpatasvir for treating chronic hepatitis C chronic hepatitis C T echnology appraisal guidance Published: 25 January 2017 nice.org.uk/guidance/ta430 © NICE 2018. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and-conditions#notice-of- rights).Y Y our responsibility our responsibility The recommendations in this guidance represent the view of NICE, arrived (...) . Commissioners and providers have a responsibility to promote an environmentally sustainable health and care system and should assess and reduce the environmental impact of implementing NICE recommendations wherever possible. Sofosbuvir–velpatasvir for treating chronic hepatitis C (TA430) © NICE 2018. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and- conditions#notice-of-rights). Page 2 of 31Contents Contents 1 Recommendations 4 2 The technology 6 3 Evidence 7 4 Committee

2017 National Institute for Health and Clinical Excellence - Technology Appraisals

5. Daclatasvir and sofosbuvir treatment of decompensated liver disease or post‐liver transplant hepatitis C virus recurrence in patients with advanced liver disease/cirrhosis in a real‐world cohort Full Text available with Trip Pro

Daclatasvir and sofosbuvir treatment of decompensated liver disease or post‐liver transplant hepatitis C virus recurrence in patients with advanced liver disease/cirrhosis in a real‐world cohort We report the findings of an early access program providing treatment for chronic hepatitis C virus infection (any genotype) with daclatasvir and sofosbuvir with/without ribavirin to patients with Child-Pugh class C cirrhosis or prior liver transplant recipients with recurrent hepatitis C virus (...) infection and advanced fibrosis/cirrhosis. Patients had <12-month life expectancies per the local investigator. Patients received daclatasvir 60 mg and sofosbuvir 400 mg once daily, with/without ribavirin, for 24 weeks. Sustained virologic response (SVR) at posttreatment week 12 (SVR12) was measured. Assessments adhered to local standards. One patient (prior Child-Pugh class C who improved to class B) enrolled by exemption was included in the overall data but not the class C cohort efficacy/safety data

2018 Hepatology communications

6. Sofosbuvir/velpatasvir (chronic hepatitis C) - Benefit assessment according to §35a SGB V

Sofosbuvir/velpatasvir (chronic hepatitis C) - Benefit assessment according to §35a SGB V Extract 1 Translation of Sections 2.1 to 2.13 of the dossier assessment Sofosbuvir/Velpatasvir (chronische Hepatitis C) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 13 October 2016). Please note: This translation is provided as a service by IQWiG to English-language readers. However, solely the German original text is absolutely authoritative and legally binding. IQWiG Reports – Commission (...) No. A16-48 Sofosbuvir/velpatasvir (chronic hepatitis C) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A16-48 Version 1.0 Sofosbuvir/velpatasvir (chronic hepatitis C) 13 October 2016 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Sofosbuvir/velpatasvir (chronic hepatitis C) – Benefit assessment according to §35a Social Code Book V Commissioning agency

2017 Institute for Quality and Efficiency in Healthcare (IQWiG)

7. Sovaldi - Sofosbuvir

Sovaldi - Sofosbuvir Search Page - Drug and Health Product Register Language selection Search and menus Search Search website Search Topics menu You are here: Summary Basis of Decision - - Health Canada Expand all Summary Basis of Decision (SBD) for Contact: Summary Basis of Decision (SBD) documents provide information related to the original authorization of a product. The for is located below. Recent Activity for SBDs written for approved after September 1, 2012 will be updated to include

2018 Health Canada - Drug and Health Product Register

8. EPCLUSA (sofosbuvir/velpatasvir), fixed combination of direct-acting antivirals

EPCLUSA (sofosbuvir/velpatasvir), fixed combination of direct-acting antivirals Haute Autorité de Santé - EPCLUSA (sofosbuvir/velpatasvir), association fixe d’antiviraux à action directe Développer la qualité dans le champ sanitaire, social et médico-social Recherche Évaluation & Recommandation La HAS Accréditation & Certification Outils, Guides & Méthodes Agenda Avis sur les Médicaments EPCLUSA (sofosbuvir/velpatasvir), association fixe d’antiviraux à action directe Substance active (DCI (...) ) sofosbuvir velpatasvir INFECTIOLOGIE - NOUVEAU MEDICAMENT Nature de la demande Réévaluation SMR et ASMR et Inscription Avis de la CT du 19 octobre 2016 Comme les autres antiviraux d’action directe (HARVONI, DAKLINZA, OLYSIO, VIEKIRAX, EXVIERA), progrès thérapeutique mineur dans le traitement de l’hépatite C chronique de génotypes 1 à 6. EPCLUSA a l’AMM dans le traitement de l’hépatite C chronique chez l’adulte infecté par un virus de l’hépatite C (VHC) de génotypes 1 à 6. Son efficacité virologique

2017 Haute Autorite de sante

9. Adverse effects of pseudoephedrine and sofosbuvir

Adverse effects of pseudoephedrine and sofosbuvir Prescrire IN ENGLISH - Spotlight ''In the January issue of Prescrire International: adverse effects of pseudoephedrine and sofosbuvir'', 1 January 2017 {1} {1} {1} | | > > > In the January issue of Prescrire International: adverse effects of pseudoephedrine and sofosbuvir Spotlight Every month, the subjects in Prescrire’s Spotlight. 100 most recent :  |   |   |   |   |   |   |   |  (...)  |  Spotlight In the January issue of Prescrire International: adverse effects of pseudoephedrine and sofosbuvir FREE DOWNLOAD In the "Adverse Effects" section of this month's issue, ischaemic colitis with the decongestant pseudoephedrine, and a risk of pulmonary arterial hypertension with the hepatitis C drug sofosbuvir. Full text available for free download. Pseudoephedrine: ischaemic colitis Sympathomimetic vasoconstrictors can provoke neurological and cardiovascular adverse effects

2017 Prescrire

10. Sofosbuvir Use in the Setting of End-stage Renal Disease: A Single Center Experience Full Text available with Trip Pro

Sofosbuvir Use in the Setting of End-stage Renal Disease: A Single Center Experience Background and Aims: Patients with chronic hepatitis C (CHC) and end-stage renal disease (ESRD) who are dialysis-dependent form a unique group, in which safety, tolerability and efficacy of sofosbuvir (SOF)-based direct-acting antivirals (DAAs) need further evaluation. Methods: We performed a retrospective analysis of 14 patients with CHC and ESRD on dialysis who received 15 courses of SOF-based therapy. We

2017 Journal of clinical and translational hepatology

11. Sofosbuvir-velpatasvir (Epclusa) - chronic hepatitis C virus (HCV)

Sofosbuvir-velpatasvir (Epclusa) - chronic hepatitis C virus (HCV) Published 9 April 2018 1 Re-Submission sofosbuvir 400mg, velpatasvir 100mg film-coated tablets (Epclusa ® ) SMC No 1271/17 Gilead Sciences Ltd 9 March 2018 The Scottish Medicines Consortium (SMC) has completed its assessment of the above product and advises NHS Boards and Area Drug and Therapeutic Committees (ADTCs) on its use in NHS Scotland. The advice is summarised as follows: ADVICE: following a resubmission sofosbuvir (...) -velpatasvir (Epclusa ® ) is accepted for restricted use within NHS Scotland. Indication under review: treatment of chronic hepatitis C virus (HCV) infection in adults. SMC restriction: in patients with genotype 1 or 4 HCV infection. Sofosbuvir-velpatasvir was associated with high rates of sustained virologic suppression in adults with genotype 1 and 4 chronic HCV infection, including those with decompensated cirrhosis. This SMC advice takes account of the benefits of a Patient Access Scheme (PAS

2018 Scottish Medicines Consortium

12. Hepatitis C: sofosbuvir + velpatasvir (Epclusa) represents an advance for some patients

Hepatitis C: sofosbuvir + velpatasvir (Epclusa) represents an advance for some patients Prescrire IN ENGLISH - Spotlight ''Hepatitis C: sofosbuvir + velpatasvir (Epclusa°) represents an advance for some patients'', 1 April 2018 {1} {1} {1} | | > > > Hepatitis C: sofosbuvir + velpatasvir (Epclusa°) represents an advance for some patients Spotlight Every month, the subjects in Prescrire’s Spotlight. 100 most recent :  |   |   |   |   |   |    (...) |   |   |  Spotlight Hepatitis C: sofosbuvir + velpatasvir (Epclusa°) represents an advance for some patients The combination sofosbuvir + velpatasvir (Epclusa°) offers a therapeutic advance in the treatment of hepatitis C, especially in patients infected by a genotype 2 virus. But the uncertainty surrounding its adverse effects is unacceptable. Hepatitis C can cause complications such as cirrhosis and liver cancer. Treatment depends on the virus genotype, the severity

2018 Prescrire

13. Harvoni - sofosbuvir / ledipasvir

Harvoni - sofosbuvir / ledipasvir 25 September 2014 EMA/702742/2014 Committee for Medicinal Products for Human Use (CHMP) Assessment report Harvoni International non-proprietary name: ledipasvir / sofosbuvir Procedure No. EMEA/H/C/003850/0000 Note Assessment report as adopted by the CHMP with all information of a commercially confidential nature deleted. 30 Churchill Place ? Canary Wharf ? London E14 5EU ? United Kingdom An agency of the European Union Telephone +44 (0)20 3660 6000 Facsimile (...) -Cyclen Lo OCT organic cation transporter Peg-IFN pegylated interferon P-gp p-glycoprotein PI protease inhibitor PopPK Population Pharmacokinetics PXR Pregnane X receptor Q QD Quartile Once Daily /r boosted with ritonavir RAL raltegravir RAV resistance-associated variant RBV ribavirin SOF sofosbuvir Assessment report EMA/702742/2014 Page 4/80 SVR sustained virologic response TE treatment experienced TFV Tenofovir TGV Tegobuvir TN treatment naive UGT uridine disphosphate glucuronosyltransferase ULN

2014 European Medicines Agency - EPARs

14. Clinical review report. Sofosbuvir (Sovaldi ? Gilead Sciences Canada, Inc.) indication: chronic hepatitis C infection

Clinical review report. Sofosbuvir (Sovaldi ? Gilead Sciences Canada, Inc.) indication: chronic hepatitis C infection Clinical review report. Sofosbuvir (Sovaldi — Gilead Sciences Canada, Inc.) indication: chronic hepatitis C infection Clinical review report. Sofosbuvir (Sovaldi — Gilead Sciences Canada, Inc.) indication: chronic hepatitis C infection CADTH Record Status This is a bibliographic record of a published health technology assessment from a member of INAHTA. No evaluation (...) of the quality of this assessment has been made for the HTA database. Citation CADTH. Clinical review report. Sofosbuvir (Sovaldi — Gilead Sciences Canada, Inc.) indication: chronic hepatitis C infection. Ottawa: Canadian Agency for Drugs and Technologies in Health (CADTH). CDR Clinical Review Report; SR0356. 2014 Authors' conclusions There were four RCTs included in this review that enrolled patients with genotypes 2 or 3 (FISSION, FUSION, POSITRON, and VALENCE), but only one single-arm study (NEUTRINO

2014 Health Technology Assessment (HTA) Database.

15. Shortened 8-Week Course of Sofosbuvir/Ledipasvir Therapy in Adolescents with Chronic Hepatitis C Infection. (Abstract)

Shortened 8-Week Course of Sofosbuvir/Ledipasvir Therapy in Adolescents with Chronic Hepatitis C Infection. Treatment-naïve, non-cirrhotic adults with chronic hepatitis C virus (HCV) genotype 1 infection and with viremia levels < 6 million IU/mL could be effectively treated with sofosbuvir/ledipasvir for 8 weeks. The aim of this pilot, prospective, open-label, multicentre study was to evaluate the efficacy and safety of this shortened treatment course in adolescents (≥ 12 years). The efficacy (...) of the shortened 8-week treatment with sofosbuvir/ledipasvir for treatment-naïve, non-cirrhotic adolescents with chronic HCV genotype 1 infection and pre-treatment viremia level < 6 million IU/mL.

2019 Journal of Pediatric Gastroenterology and Nutrition

16. Real-world effectiveness and safety of ledipasvir/sofosbuvir for genotype 6 chronic hepatitis C patients in Taiwan. (Abstract)

Real-world effectiveness and safety of ledipasvir/sofosbuvir for genotype 6 chronic hepatitis C patients in Taiwan. Infection with hepatitis C virus (HCV) genotype (GT) 6 is uncommon in Taiwan, and reports of ledipasvir/sofosbuvir (LDV/SOF) treatment for GT6 are few. This study evaluates the effectiveness and safety of LDV/SOF in treating chronic hepatitis C (CHC) patients with GT6 infection.CHC patients that were infected with GT6 and treated for 12 weeks with LDV/SOF at two hospitals were

2019 Journal of gastroenterology and hepatology

17. Cost-effectiveness analysis of sofosbuvir plus ribavirin in patients with genotype 2 chronic hepatitis C: an analysis with real world outcomes from a multicentre cohort in Japan. Full Text available with Trip Pro

Cost-effectiveness analysis of sofosbuvir plus ribavirin in patients with genotype 2 chronic hepatitis C: an analysis with real world outcomes from a multicentre cohort in Japan. A number of publications have demonstrated the cost-effectiveness of sofosbuvir plus ribavirin (SOF+RBV) compared with the former standard therapy with interferon (IFN)-containing regimens. Unlike these cost-effective analyses, where efficacy parameters were obtained from registration trials for drug approval

2019 BMJ open

18. Ledipasvir/Sofosbuvir for 8 Weeks to Treat Acute Hepatitis C Virus Infections in Men With Human Immunodeficiency Virus Infections: Sofosbuvir-Containing Regimens Without Interferon for Treatment of Acute HCV in HIV-1 Infected Individuals. Full Text available with Trip Pro

Ledipasvir/Sofosbuvir for 8 Weeks to Treat Acute Hepatitis C Virus Infections in Men With Human Immunodeficiency Virus Infections: Sofosbuvir-Containing Regimens Without Interferon for Treatment of Acute HCV in HIV-1 Infected Individuals. Current guidelines for the management of hepatitis C virus (HCV) infections provide varying recommendations for the optimal treatment of acute HCV infections. There are limited data from small cohort studies to provide guidance on the best approach (...) to treatment of this important patient population.Sofosbuvir-Containing Regimens Without Interferon for Treatment of Acute HCV in HIV-1 Infected Individuals is an open-label, 2-cohort, Phase 1 clinical trial in which the second cohort assessed the safety and efficacy of 8 weeks of ledipasvir/sofosbuvir for the treatment of acute HCV infections in participants with chronic human immunodeficiency virus (HIV)-1 infections. This final analysis of the second cohort had a planned accrual of 27 participants

2019 Clinical Infectious Diseases

19. Ledipasvir-Sofosbuvir for 12 Weeks in Children 3 to &lt;6 Years Old With Chronic Hepatitis C. Full Text available with Trip Pro

Ledipasvir-Sofosbuvir for 12 Weeks in Children 3 to <6 Years Old With Chronic Hepatitis C. For children under 12 years of age who have chronic hepatitis C virus (HCV) infection, there are currently no approved treatments with direct-acting antiviral agents. We therefore evaluated the safety and efficacy of ledipasvir-sofosbuvir in HCV-infected children aged 3 to <6 years old. In an open-label study, patients 3 to <6 years old chronically infected with HCV genotype 1 (n=33) or 4 (n=1 (...) ) received weight-based doses of combined ledipasvir-sofosbuvir as granules (33.75 mg/150 mg for weights <17 kg or 45 mg/200 mg for weights ≥17 kg) for 12 weeks. The primary endpoint was sustained virologic response 12 weeks after treatment (SVR12). For the first 14 patients, intensive pharmacokinetic sampling was done on day 10 of treatment. All patients had been infected through perinatal transmission and were treatment naïve. No patients had known cirrhosis. Ten patients (29%) weighed <17 kg. SVR12

2019 Hepatology

20. Sofosbuvir/Velpatasvir for 12 Weeks in Hepatitis C Virus-Infected Patients with End-Stage Renal Disease Undergoing Dialysis. Full Text available with Trip Pro

Sofosbuvir/Velpatasvir for 12 Weeks in Hepatitis C Virus-Infected Patients with End-Stage Renal Disease Undergoing Dialysis. Although off-label use of sofosbuvir-containing regimens occurs regularly in patients with hepatitis C virus (HCV) infection undergoing dialysis for severe renal impairment or end-stage renal disease (ESRD), these regimens are not licensed for this indication, and there is an absence of dosing recommendations in this population. This study evaluated the safety (...) and efficacy of sofosbuvir/velpatasvir in patients with HCV infection with ESRD undergoing dialysis.In this phase 2, single-arm study, 59 patients with genotype 1-6 HCV infection with ESRD undergoing hemodialysis or peritoneal dialysis received open-label sofosbuvir/velpatasvir (400 mg/100 mg) once daily for 12 weeks. Patients were HCV treatment naive or treatment experienced without cirrhosis or with compensated cirrhosis. Patients previously treated with any HCV NS5A inhibitor were not eligible

2019 Journal of Hepatology